Dr. Robert Califf - FDA

An expert on the trials of drug development

Name: Dr. Robert Califf
Title: FDA Deputy Commissioner for Medical Products and Tobacco

Dr. Robert Califf's influence over the international pharma world is both real and presumptive.

The U.S. is the largest, most valuable pharma market in the world, and to be granted access to it, drugmakers need to go through the FDA advisory committee system. As deputy commissioner for medical products and tobacco, Califf has authority over that essential system. It doesn't get any more real than that.

But it also presumed that FDA Commissioner Margaret Hamburg, who left the agency in March, brought in the well-regarded academic and industry insider in hopes that President Barack Obama would name him FDA commissioner before an administration change in 2017. To get the job would require Senate confirmation, but with decades of experience in academia and the industry, Califf is the kind of global pro that could pass muster with any administration and either party. In fact, Califf has twice before been considered for the top role at the FDA, having been interviewed once by the administration of the last President Bush and by Obama's team before Hamburg was selected.

"He is one of the few candidates who could sail through the confirmation process because of his universally recognized talents," FDA vet Peter Pitts observed when Califf was named to his new role.

Hamburg said he will have a hand in a spectrum of FDA initiatives such as personalized medicine, orphan drugs, pediatric science, as well as the advisory committee system. Some see his experience as both a clinician and working closely with industry as providing him with rare insight into the difficulties of identifying a medical need and going through the arduous process of getting a drug to market. He is seen as an advocate of change at the FDA, having spoken publicly about the need to make the regulatory process more efficient so that drugs can get to market faster and at less expense, but then so has Dr. Hamburg.

Still some suggest his background may make him a little too cozy with industry. One of those is Diana Zuckerman, president of the National Center for Health Research, who Time magazine recently quoted as saying that while Dr. Califf is "a very accomplished, smart physician," his ties to industry might make some wonder about his "objectivity and distance."

So what all is on his curriculum vitae? He has rich experience in clinical research as the founding director of the in-house CRO, Duke Clinical Research Institute, which has about 1,000 employees and conducts about $320 million in research annually, at least half of that paid for by the industry. He is considered an expert in translational medicine, having run the Duke Translational Medicine Institute, which works with the National Institutes of Health to turn lab discoveries into actionable medicines.

He has also seen action from the business side of the line. He led the 6-year IMPROVE-IT study, from which the positive outcomes of Merck's ($MRK) Zetia are expected to pave the way for approval of PCSK9 inhibitors. The meds, which help statin-intolerant patients lower their bad cholesterol, are expected to grow into a $10-billion-a-year market. Amgen ($AMGN), Pfizer ($PFE) and a partnership of Sanofi ($SNY) and Regeneron ($REGN) are all playing in that field. His ties to the Merck drug could raise some eyebrows when competitors come looking for approvals.

Califf was also a member of the board at Portola Pharmaceuticals ($PTLA), a biotech working on antidotes to next-generation anticoagulants, but resigned that position to serve at the FDA. What the 63-year-old Califf didn't give up, however, is his tie to Duke, where he most recently was vice chancellor of clinical and translational research. Instead he is taking a leave of absence from the school where he has been for 33 years. Showing his pragmatic side, the doctor observed in a call with reporters when he was named to the FDA that with a new occupant taking up residence in the White House in 2017, he might yet need someplace to land.

-- Eric Palmer (email | Twitter)

For more:
FDA chief Hamburg is stepping down. Is Califf the next commissioner?
FDA picks Duke's Califf as deputy chief, spurring succession rumors
U.S. rep rips the FDA's efforts to speed up drug approvals
FDA's Hamburg touts rising approval record and promises swifter interaction

Dr. Robert Califf - FDA
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